Recall Z-2366-2015 ยท MOS Coil, Magnetic Resonance, Specialty
Hitachi Medical Systems America Inc
Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal st
| Date | Aug 10, 2015 (initiated Apr 25, 2014) |
| Status | Terminated |
| Reason | The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched. |
| Root cause | Nonconforming Material/Component |
| Action | Hitachi sent an Urgent: Device Removal Notice letter date April 24, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue using the Coil Extension Cable and that a Field Service Engineer will schedule a visit to remove the cable. For questions call 800-800-3106 ext 3720. |
| Quantity | 173 units |
| Distribution | US Nationwide in the states: AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WY and the country of Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072279 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE Hitachi Medical Systems America, Inc., Sep 21, 2007 |